scholarly journals Pharmacological Management of Diabetic Macular Edema in Real-Life Observational Studies

2018 ◽  
Vol 2018 ◽  
pp. 1-16 ◽  
Author(s):  
Laurent Kodjikian ◽  
David Bellocq ◽  
Thibaud Mathis

Objectives of the Study. Summary of observational studies concerning the pharmacological management of diabetic macular edema (DME). Methods. A literature review was conducted using the PubMed database on 1 February 2018 to identify studies evaluating the efficacy of anti-VEGF and dexamethasone (DEX) implants for DME. Studies with more than 10 patients and follow-up of more than 6 months were selected. Analyses were carried out on the overall population and on subgroups defined according to baseline visual acuity (BVA) and the patients’ naïve or non-naïve status. Results. Thirty-two studies evaluating the efficacy of anti-VEGF and 31 studies evaluating the efficacy of DEX-implants were retained, concerning 6,842 and 1,703 eyes, respectively. A mean gain of +4.7 letters for a mean of 5.8 injections (mean follow-up: 15.6 months) and +9.6 letters for a mean of 1.6 injections (10.3 months) was found in the anti-VEGF and DEX-implant studies, respectively. Final VA appears to be similar for both treatment (62 letters for anti-VEGF, 61.2 letters for DEX-implant), and BVA appears lower for DEX-implant, which may partially explain the greater visual gain. The DEX-implant studies show greater gains in VA compared to the anti-VEGF studies, especially for higher BVA. Indeed, mean gains for the subgroups of patients with BVA<50 letters, 50<BVA<60 letters, and BVA>60 letters are +4.3, +5.8, and +3.1 letters, respectively, in the anti-VEGF studies and +10.5, +9.3, and +8.8 letters, respectively, in the DEX-implant studies. Regarding the patient’s initial status, only naïve status appears to confer the best functional response in DEX-implant studies. Conclusion. Observational studies investigating DEX-implant report clinically similar final VA when compared to anti-VEGF, but superior visual gains in real-life practice. This latter difference could be due to the better BVA, but also to the fact that less injections were administered in the anti-VEGF observational studies than in the interventional studies.

2018 ◽  
Vol 08 (02) ◽  
pp. 008-014
Author(s):  
Abdullah Ozkaya ◽  
Mehmet Ozveren ◽  
Okkes Baz ◽  
Hatice Nur Tarakcioglu ◽  
Korhan Fazil ◽  
...  

Abstract Purpose: We aimed to evaluate the real life outcomes of ranibizumab in the treatment of diabetic macular edema (DME) patients with a baseline visual acuity<0.05 in decimals. Methods: Newly diagnosed DME patients with a visual acuity ≤0.05, treated with ranibizumab monotherapy, and completed a follow-up time of 12 months were included retrospectively. Patients were evaluated in regards to change in best corrected visual acuity (BCVA) and central retinal thickness, and the total visit and injection numbers. Results: A total of 24 eyes of 24 patients were included. Mean BCVA at baseline, month 3, 6, 9, and 12 was, 0.04±0.01, 0.12±0.12, 0.12±0.11, 0.17±0.19, and 0.21±0.21 (p<0.05 for all), respectively. One eye (4.2%) had VA loss of ≥3 lines, and six eyes (25.0%) had stable vision (loss of <3 line, or remained stable, or gained <1 lines), and 17 eyes (70.8%) had VA gain of ≥3 lines at month 12.The mean visit number at month 12 was 4.8±1 and the mean injection number was 4.0 ±1.4. Conclusion: Ranibizumab seemed to be effective in the treatment of DME patients with a low visual acuity in real life.


2019 ◽  
Vol 243 (6) ◽  
pp. 413-419 ◽  
Author(s):  
Daniele De Geronimo ◽  
Paola Giorno ◽  
Fabio Scarinci ◽  
Antonluca Boninfante ◽  
Monica Varano ◽  
...  

<b><i>Objective:</i></b> To gain information about multiple dexamethasone intravitreal implant (DEX-I) injections in diabetic macular edema (DME) eyes in real-life clinical settings. <b><i>Methods:</i></b> Patients with DME treated with multiple (≥5) DEX-I injections between January 1, 2014, and December 31, 2018, were retrospectively enrolled regardless of previous treatment with anti-VEGF agents. All patients were evaluated with best-corrected visual acuity (BCVA) in logMAR, ocular fundus, and spectral domain optical coherence tomography (SD-OCT) at baseline and at 3 months after the last DEX-I injection. Multiple DEX-I injections were administered when necessary in case of DME recurrence. Main efficacy measures were changes in BCVA and central retinal thickness (CRT) from baseline to 3 months after the last DEX-I injection; main secondary measures were an increase in intraocular pressure (IOP), the need for cataract surgery, endophthalmitis, and vitreous hemorrhage. <b><i>Results:</i></b> Seventeen patients (18 eyes) with DME and mean age (± SD) of 54.3 ± 8.16 years were treated with DEX-I injections between 2014 and 2018. The majority of eyes (77.8%) had been treated with a mean of 6.3 ± 3.2 anti-VEGF agents before switching to DEX-I. During a mean follow-up period of 37.6 months and after a mean number of 5.9 DEX-I injections, visual acuity improved or stabilized in 77.8% of all eyes, accompanied by a significant reduction in CRT. An increase in IOP was recorded in 38.8% of all patients, while a surgical procedure was needed for cataract in 73.3% of all phakic patients. <b><i>Conclusions:</i></b> In this real-life experience in Italy, multiple DEX-I treatments showed good efficacy with no new safety concerns. The follow-up duration of &#x3e;3 years and a greater number of DEX-I intravitreal injections compared to other observations confirm the positive balance between risks and benefits of DEX-I in the long term.


2017 ◽  
Vol 2017 ◽  
pp. 1-4 ◽  
Author(s):  
Filipe Mira ◽  
Manuel Paulo ◽  
Filipe Henriques ◽  
João Figueira

Purpose. The aim was to evaluate the efficacy of aflibercept in patients with diabetic macular edema (DME) unresponsive to prior anti-VEGF therapy. Methods. Retrospective review of DME unresponsive to previous anti-VEGF switched to aflibercept with 3 months of follow-up. Changes in best correct visual acuity (BCVA), central retinal thickness (CRT), and frequency of injections were analyzed. The percentage of subjects who had ≥20/40 (logMAR equivalent 0.3) and ≤20/200 (logMAR equivalent 1) was evaluated. Results. A total of 32 eyes from 26 patients were included. Mean age was 65 ± 10 years old. The mean number of previous anti-VEGF injections was 5.34 ± 2.38, and the mean number of aflibercept injections at the end of the study was 2.00 ± 0.00. The CRT at baseline was 501.47 ± 150.51 μm and 367.97 ± 124.61 μm at 3 months of follow-up (P<0.001). The logMAR BCVA at baseline was 0.71 ± 0.36 and 0.65 ± 0.33 at the end of the follow-up (P=0.037). At baseline, 12.5% of patients had ≥20/40 compared with 25% at the end of follow-up. At baseline, 28.13% of patients had 20/200 or inferior vision compared with 15.63% at the end of the follow-up. Conclusions. DME patients unresponsive to previous multiple ranibizumab injections demonstrate a significant anatomical and functional improvement with the switch to aflibercept.


2020 ◽  
Vol 161 (49) ◽  
pp. 2078-2085
Author(s):  
Mónika Ecsedy ◽  
Illés Kovács ◽  
Róbert Gergely ◽  
Katalin Gombos ◽  
Judit Meisel ◽  
...  

Összefoglaló. Bevezetés és célkitűzés: A Navilas® 577s mikropulzuslézerrel végzett kezelés biztonságosságának és hatásosságának vizsgálata diabeteses maculaoedemában. Módszer: Retrospektív vizsgálatunkba diabeteses maculaoedema miatt gondozott és legalább 6 hónapos utánkövetéssel rendelkező, korábban Navilas® 577s mikropulzuslézer-kezelésen átesett 28 beteg 46 szemét válogattuk be. Minden szemen optikaikoherencia-tomográfia (OCT) vastagsági térkép navigált, nonkontakt, küszöb alatti mikropulzuslézer-kezelés történt egy alkalommal. A kezelést megelőzően és az azt követő 6. hónapban rögzítettük a látóélesség, a centrális retinavastagság értékeit és az éreredetű endothelialis növekedési faktort (VEGF) gátló injekciók számát. A követési idő végén megvizsgáltuk a szemfenéki képnek a digitális fundusfotográfia és az átmetszeti OCT-képek segítségével észlelhető változásait. Eredmények: A vizsgált szemek közül 30 esetben a lézerkezelést korábbi centrális maculaoedema miatt VEGF-gátló injekciós kezelés előzte meg, míg 16 szem esetében primer lézerkezelés történt. A Navilas® 577s mikropulzuslézer-kezelést követően 6 hónappal sem a látóélesség, sem a centrális maculavastagság nem változott szignifikánsan egyik csoportban sem (p>0,05). Ugyanakkor a korábban injekciós kezelésben részesült szemek esetében a lézerkezelést megelőző 6 hónapban adott injekciók száma az átlagos 2,63 ± 1,18 értékről átlagosan 0,5 ± 0,73 értékre csökkent (p<0,001). A fundusfotókon és az átmetszeti OCT-scaneken a lézerkezelést követően egyetlen szem esetében sem találtunk látható pigmentelváltozásokat vagy hegesedést. Következetetés: Megfigyeléseink szerint a Navilas® 577s mikropulzuslézer-kezelés biztonságos a diabeteses maculaoedemás betegek kezelésében, továbbá a VEGF-gátlóval kezelt szemeken szerepet játszhat az injekciók számának csökkentésében. Orv Hetil. 2020; 161(49): 2078–2085. Summary. Introduction and objective: To assess the safety and efficacy of Navilas® 577s micropulse subthreshold laser in the treatment of non-center involved diabetic macular edema. Method: In this retrospective study, we included 46 eyes of 28 patients with diabetic macular edema, who were treated at least 6 months ago with Navilas® 577s micropulse laser. Laser treatment was navigated by optical coherence tomography (OCT) macular thickness map in subthreshold micropulse mode at one occasion. Data from visual acuity testing, retinal thickness, and the number of anti-vascular endothelial growth factor (VEGF) injections needed 6 months before and after treatment were registered. At the end of the follow-up, digital fundus photography and OCT radial scans were performed to evaluate any possible anatomical changes. Results: 30 eyes had previous anti-VEGF treatment for central macular edema, and in 16 eyes we performed the laser as primary treatment. At the end of the follow-up, no significant visual acuity or central retinal thickness change were observed (p>0.05). On the other hand, in the anti-VEGF pretreated group the number of injections decreased significantly from 2.63 ± 1.18 to 0.5 ± 0.73 (p<0.001). We did not find any pigmentary changes or visible signs of scaring on final fundus photography pictures or OCT radial scans. Conclusion: Navilas® 577s subthreshold microsecond laser proved to be a safe option in the treatment of diabetic macular edema. It can be very useful in anti-VEGF treated eyes by decreasing the number of injections needed. Orv Hetil. 2020; 161(49): 2078–2085.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Ji Soo Kim ◽  
Seungheon Lee ◽  
Jin Young Kim ◽  
Eoi Jong Seo ◽  
Ju Byung Chae ◽  
...  

AbstractTo investigate the visual/anatomical outcome of diabetic macular edema (DME) patients lost to follow-up (LTFU) for more than 1 year during intravitreal anti-VEGF treatment. A retrospective review of 182 treatment-naïve DME patients was performed. Among them, we identified patients LTFU for more than 1 year during anti-VEGF treatment. Visual acuity and anatomic outcomes at the first visit, last visit before being LTFU, return visit, and after re-treatment were analyzed and compared with those of DME patients with regular follow-up. Patients who had continuous follow-up visits were assigned to the control group. Sixty patients (33%) with DME were LTFU for more than 1 year during anti-VEGF treatment. Multivariate analysis revealed that the ratio of male (p = 0.004), diabetes mellitus (DM) duration less than 5 years (p = 0.015), and poor early anatomic response (p = 0.012) were higher compared to the control group. Eighteen patients returned to the clinic and received re-treatment. After re-treatment with anti-VEGF, central subfield thickness (CST) was significantly improved to the CST of before LTFU. However, visual acuity did not recover to the level before LTFU (0.63 ± 0.26 vs. 0.45 ± 0.28, p = 0.003). About thirty percent of DME patients were LTFU for more than 1 year. Permanent visual loss was observed in these LTFU patients. Patients with a high risk of LTFU such as male, early DM, and poor response after initial injections should be treated more aggressively to improve the visual outcomes.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Erhan Yumuşak ◽  
Kemal Örnek

Purpose. To compare the efficacy of perioperative ranibizumab injections on diabetic macular edema (DME) in patients undergoing cataract surgery.Methods. This study included 59 eyes of 59 patients. All patients had advanced cataract with DME and underwent an uneventful phacoemulsification surgery. There were 3 subgroups. The first group received intravitreal ranibizumab injection 2 weeks preoperatively, the second group received intraoperatively, and the third group received 2 weeks postoperatively. Follow-up examinations were performed at 1 week as well as at 1 and 3 months.Results. Baseline visual acuity showed a significant increase in all groups at 1 month. In group 1, compared to baseline value, foveal thickness (FT) increased significantly at 1 month and showed a significant decrease up to month 3. In group 2, FT increased at month 1 and this continued up to month 3. In group 3, FT increased at month 1 and was almost stable up to month 3. There were not any significant differences for visual acuity and FT between the groups.Conclusions. Although intrapostoperative ranibizumab injection for DME seems to be more effective than preoperative injections in patients undergoing cataract surgery, the treatment still needs to be continued following surgery.


2020 ◽  
Author(s):  
Nardine Sharef ◽  
Rabea Kassem ◽  
Idan Hecht ◽  
Asaf Bar ◽  
Idit Maharshak ◽  
...  

Introduction: We have recently shown that defects in interdigitation and ellipsoid zones (IZ and EZ) can predict response to anti-VEGF therapy in a small group of treatment-naïve diabetic macular edema (DME) patients. The aim of the current study is to further evaluate this association in a larger study group of patients over a longer follow-up time. Methods: Thirty eyes of 30 treatment-naïve DME patients were analyzed in this retrospective study. The integrity of foveal IZ and EZ was evaluated using OCT at the diagnosis of DME and following anti-VEGF injections. The defect size was correlated with best-corrected visual acuity (BCVA) and central macular thickness (CMT). Results: The mean patients' age at baseline was 63.0±10.0 years. Patients underwent 3.9±2.9 anti-VEGF injections for a mean of 9.1±4.8 months. Following treatment, the mean Snellen visual acuity improved from 20/52 to 20/44 (p=0.05), CMT decreased from 432.5±141.4 m to 375.2±121.4 µm (p=0.05) and IZ/EZ defect size decreased from 259.83±375.94 µm to 65.34±143.97 µm (p=0.001). In patients with no IZ/EZ defects at baseline the mean Snellen visual acuity was better when compared to those with IZ/EZ defects (20/36 vs. 20/70, p=0.031). The number of eyes with IZ/EZ defects decreased from 17 (57%) at baseline to 6 (20%) at end of follow-up (p<0.01). BCVA gain correlated with IZ/EZ defect size reduction (r=0.41, p=0.02) but not with improvement in CMT (r=0.28, p=0.121). Conclusions: IZ/EZ defect size correlated not only with baseline BCVA, but also predicted the change in BCVA after anti-VEGF treatment. Possible future automatic measurement of IZ/EZ defect size might prove helpful for evaluation of treatment response.


2020 ◽  
Vol 36 (3) ◽  
Author(s):  
Muhammad Ali Haider ◽  
Uzma Sattar ◽  
Syeda Rushda Zaidi

Purpose: To evaluate the change in visual acuity in relation to decrease in central macular thickness,after a single dose of intravitreal Bevacizumab injection.Study Design: Quasi experimental study.Place and Duration of Study: Punjab Rangers Teaching Hospital, Lahore, from January 2019 to June 2019.Material and Methods: 70 eyes with diabetic macular edema were included in the study. Patients having high refractive errors (spherical equivalent of > ± 7.5D) and visual acuity worse than +1.2 or better than +0.2 on log MAR were excluded. Central macular edema was measured in μm on OCT and visual acuity was documentedusing Log MAR chart. These values were documented before and at 01 month after injection with intravitrealBevacizumab. Wilcoxon Signed rank test was used to evaluate the difference in VA beforeand after the anti-VEGF injection. Difference in visual acuity and macular edema (central) was observed,analyzed and represented in p value. P value was considered statistically significant if it was less than 0.01%.Results: Mean age of patients was 52.61 ± 1.3. Vision improved from 0.90 ± 0.02 to 0.84 ± 0.02 on log MARchart. The change was statistically significant with p value < 0.001. Central macular thickness reduced from 328 ±14 to 283 ± 10.6 μm on OCT after intravitreal anti-VEGF, with significant p value < 0.001.Conclusion: A 45 μm reduction in central macular thickness was associated with 0.1 Log MAR unit improvementin visual acuity after intravitreal Bevacizumab in diabetic macular edema.


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